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Epidemiol. Infect. (2009), 137, 1041–1048. f 2009 Cambridge University Press
doi:10.1017/S095026880800174X Printed in the United Kingdom
Impact on rates and time to first central vascular-associated
bloodstream infection when switching from open to
closed intravenous infusion containers in a hospital setting
F. F R A N Z E T T I 1, B. BO R G HI 2, F. R A IM O N DI 2 A N D V. D. R O S E N T H A L 3*
1
Infectious Diseases Clinic, Sacco Hospital, Milan, Italy
Intensive Care Unit, Sacco Hospital, Milan, Italy
3
Medical College of Buenos Aires, Argentina
2
(Accepted 19 November 2008; first published online 15 January 2009)
SUMMARY
An open-label, prospective cohort, active healthcare-associated infection surveillance sequential
study was conducted in four Italian intensive-care units. The aim was to determine the effect of
switching from open (glass) to closed fully collapsible plastic intravenous (i.v.) infusion containers
(Viaflo1) on rate and time to onset of central venous catheter-associated bloodstream infections
(CVC-BSI). A total of 1173 adult patients were enrolled. The CVC-BSI rate during the open
container period was significantly higher than during the closed container period (8.2 vs.
3.5 BSI/1000 CVC days, relative risk 0.43, 95 % confidence interval 0.22–0.84, P=0.01).
The probability of developing a CVC-BSI was assessed over time comparing open and closed i.v.
infusion containers. In the closed container period, it remained fairly constant (0.8 % at days 1–3
to 1.4% at days 7–9) whereas during the open container period it increased (2 % at days 1–3 to
5.8% at days 7–9). Overall, the chance of acquiring a CVC-BSI significantly decreased by 61% in
the closed container period (Cox proportional hazard ratio 0.39, P=0.004).
Key words: Bloodstream infection, central venous catheter, closed and open infusion containers,
intensive care unit, healthcare-associated infection.
INTRODUCTION
Hospitalized patients are at risk for bloodstream infections (BSIs), especially within intensive-care units
(ICUs). Most BSIs originate from central vascular
catheters (CVCs) [1] and they extend hospitalization,
increase attributable costs of healthcare and mortality
[2]. The efficacy of nosocomial infection surveillance
programmes has been demonstrated in both Western
Europe and the United States [3, 4]. The Centers for
Disease Control and Prevention (CDC) Intravenous
* Author for correspondence : Dr V. D. Rosenthal, Medical
College of Buenos Aires, Lavalleja 305, Floor 9, Apt B, ZIP 1414,
Buenos Aires, Argentina.
(Email : [email protected])
Guidelines (introduced in the 1980s and updated in
2002) [5] are used throughout the United States and
other countries. There is a high risk of contamination
of intravenous (i.v.) fluids during set-up, admixture
preparation, and administration [6, 7] and there are
additional risks of extrinsic contamination when the
system is vented, as is mandatory with open infusion
systems.
There are two types of i.v. infusion containers
(open and closed infusion systems, Fig. 1) in use
worldwide [8, 9]. Open i.v. infusion containers are
rigid (glass, burette) or semi-rigid plastic containers
that must admit air to empty (air filter or needle).
Closed i.v. infusion containers are fully collapsible
plastic containers that do not require or use any
1042
F. Franzetti and others
(a)
(b)
has an active infection control programme with a
physician trained in infectious diseases and two infection control nurses. Three of the four ICUs operate
at the highest level of complexity, providing treatment
for medical, surgical and trauma patients. The hospital ethics committee approved the protocol.
Data collection
Fig. 1. Open and closed intravenous (i.v.) infusion containers. (a) Open i.v. infusion container : glass container with air
filter. (b) Closed i.v. infusion container : fully collapsible
plastic container without air filter.
external vent (air filter or needle) to empty the solution, and injection ports are self-sealing.
In general, the use of closed infusion systems is
being incorporated into standard practice to prevent
healthcare-associated infections (HAI), e.g. catheterassociated urinary tract infections (CAUTI) [10],
ventilator-associated pneumonia (VAP) [11], surgical site infection [12], and central vascular catheterassociated bloodstream infections (CVC-BSI) [8, 9].
Outbreaks of infusion-related BSI traced to contamination of infusate in open infusion systems have
been reported in numerous countries [6, 13–17]. Other
studies have shown that extrinsic or in-use contamination plays the most important role in bacterial contamination of the infusion system [18, 19].
The clinical impact and cost-effectiveness of closed
i.v. infusion containers, compared to semi-rigid, plastic, open i.v. infusion containers, was studied in
Argentina. This showed that switching from a semirigid plastic open container to a closed i.v. infusion
container reduced the BSI rate by 64%. However, the
time to onset of CVC-BSI was not determined [9].
We report here the results of a prospective, sequential study undertaken to determine the impact
of switching from an open (glass) to a closed, fully
collapsible, plastic i.v. infusion container (Viaflo1,
Baxter S.p.A, Italy) on rate and time to onset of CVCBSI in Italy.
METHODS
Setting
The study was conducted at four ICUs in Sacco
Hospital, a university hospital (Milan, Italy). Sacco
Patients who had a CVC in place for o24 h were
enrolled from each of the study ICUs. A trained
nurse prospectively recorded on case-report forms the
patient’s gender, average severity-of-illness score
(ASIS) on ICU entry [20], device utilization, antibiotic
exposure, and all active infections identified while
in the ICU. The patient’s physicians independently
decided to obtain blood cultures. Standard laboratory
methods were used to identify microorganisms recovered from positive blood cultures.
Definitions
United States Centers for Disease Control (CDC)
National Nosocomial Infections Surveillance Systems (NNIS) programme definitions were used to
define device-associated infections : CVC-BSI (laboratory-confirmed BSI ; LCBI) and clinical primary
nosocomial sepsis ; CSEP). These definitions are given
below.
Laboratory-confirmed BSI
Criterion 1. Patient had a recognized pathogen cultured from one or more percutaneous blood cultures,
and the pathogen cultured from the blood was not
related to an infection at another site. With common
skin commensals (e.g. diphtheroids, Bacillus spp.,
Propionibacterium spp., coagulase-negative staphylococci, or micrococci), the organism was cultured
from two or more blood cultures drawn on separate
occasions.
Criterion 2. Patient had at least one of the following
signs or symptoms : fever (>38 xC), chills, or hypotension not considered to be related to an infection at
another site.
Clinical primary nosocomial sepsis. Patient had at
least one of the following clinical signs, with no other
recognized cause : fever (>38 xC), hypotension (systolic pressure <90 mmHg), or oliguria (<20 ml/h),
although blood cultures were not obtained or no
Time to BSI in open and closed container
1043
Cumulative probability of BSI
0·45
0·40
0·35
0·30
0·25
0·20
0·15
0·10
0·05
0·00
0
1
2
3
4
5
6
7
Days on CVC
8
9
10
11
12
Fig. 2. Cumulative probability of first bloodstream infection (BSI) displayed by days on central vascular catheter (CVC).
Numbers at risk for closed (&) vs. open ( ) containers : closed (day 0=507, day 4=505, day 7=123, day 10=30,
day 12=10) ; open (day 0=558, day 4=553, day 7=116, day 10=28, day 12=7).
organisms were recovered from blood cultures. There
was no apparent infection at any other site and the
physician instituted treatment for sepsis [21].
Open infusion container. Rigid (glass, burette) or semirigid plastic containers that must admit air to empty
(air filter or needle).
Closed infusion container. Fully collapsible plastic
containers that do not require or use any external vent
(air filter or needle) to empty the solution, and the
injection ports are self-sealing.
Investigational products
Baxter Viaflo1 (Baxter S.p.A), a fully collapsible
plastic bag, was used during the closed period.
Commercially available glass, open infusion system
products were used during the open period.
Study design
Active surveillance for CVC-BSI and compliance with
infection control practices continued throughout the
study using CDC NNIS methodologies, definitions
and criteria [20]. The study was designed with a leadin period followed by the open and closed container
periods. The lead-in period was designed to measure
baseline incidence of CVC-BSI and to standardize
hand hygiene (HH) and CVC care compliance. Both
the open and closed container periods covered the
same period of time and lasted an equal number of
months (March 2004–February 2005 and March
2005–February 2006, respectively).
Protocol-specified target HH and CVC care compliance was set at o70 % and o95%, respectively.
We assessed HH compliance [22], placement of gauze
on CVC insertion sites [23, 24], condition of gauze
dressing (absence of blood, moisture and gross soiling ; occlusive coverage of insertion site) [23, 24], and
documentation for date of CVC insertion. A research
nurse observed healthcare workers (physicians, nurses,
and paramedical staff) twice weekly across all work
shifts, and recorded information on a standard form.
Data analysis
Outcomes measured during the open and closed periods included the incidence density rate of CVCBSI (number of cases/1000 CVC days) and time to
CVC-BSI of patients. x2 analyses for dichotomous
variables and t test for continuous variables were
used to analyse baseline differences between periods.
Unadjusted relative risk (RR) ratios, 95 % confidence
intervals (CI) and P values were determined for all
primary and secondary outcomes. Time to first BSI
was analysed using a log-rank test and presented
graphically using Kaplan–Meier curves. In addition,
simple life-table conditional probabilities are presented graphically to help explain the changing risk of
infection over time (Fig. 2). A Cox proportional
hazards analysis was performed to estimate the hazard
function. No formal testing of the proportional hazards assumption was performed. However, the plot
of estimated survival function showed that this assumption did not appear to be severely violated.
RESULTS
During the study, 1173 patients were enrolled : 608
during the open period, and 565 during the closed
1044
F. Franzetti and others
Table 1. Patient demographics, underlying illness, length of stay, CVC-device utilization and antibiotic usage
during the two study periods
Gender
Males
Females
Endocrine diseases
Cancer
COPD
Renal impairment
Abdominal surgery
Cardiac failure
Cardiac surgery
Thoracic surgery
Trauma
Angina pectoris
Stroke
Immunodeficiency
Previous infection
Hepatic failure
ICU stay (days)
Age (yr)
Severity-of-illness score
CVC utilization per patient (days)
Antibiotic use
Open infusion
container period
(N=608)
Closed infusion
container period
(N=565)
n (%)
n (%)
424 (69.7)
184 (30.3)
168 (27.6)
16 (2.6)
86 (14.1)
59 (9.7)
22 (3.6)
85 (14.0)
450 (74.0)
2 (0.3)
3 (0.5)
362 (59.5)
17 (2.8)
41 (6.7)
22 (3.6)
17 (2.8)
376 (66.5)
189 (33.5)
164 (29.1)
17 (3.0)
99 (17.5)
40 (7.1)
35 (6.2)
93 (16.5)
415 (73.5)
2 (0.4)
3 (0.5)
329 (58.2)
40 (7.1)
40 (7.1)
24 (4.2)
24 (4.2)
Mean¡S.D.
Mean¡S.D.
4.50¡7.16
64.8¡12.91
1.70¡1.09
5.83¡7.16
4.70¡6.94
65.6¡13.03
1.83¡1.13
6.05¡7.43
Defined daily dose
(DDD)
Defined daily dose
(DDD)
1291 DDD/1000
patient-days
1340 DDD/1000
patient-days
RR
95 % CI
P value
0.95
0.88–1.03
0.24
1.05
1.14
1.24
0.73
1.71
1.18
0.99
1.08
1.08
0.98
2.53
1.05
1.17
1.52
0.88–1.26
0.58–2.24
0.95–1.62
0.50–1.07
1.02–2.88
0.90–1.54
0.93–1.06
0.15–7.61
0.22–5.31
0.89–1.08
1.45–4.41
0.69–1.60
0.67–2.07
0.82–2.80
0.60
0.70
0.11
0.11
0.04
0.24
0.83
0.94
0.93
0.65
<0.01
0.82
0.58
0.18
—
—
—
—
—
—
—
—
0.63
0.32
0.046
0.94
1.04
0.99–1.09
0.11
RR, Relative risk ; CI, confidence interval ; COPD, chronic obstructive pulmonary disease ; ICU, intensive care unit ; CVC,
central vascular catheter.
period. Patients in both periods were statistically
similar regarding patient demographics, underlying
illness, length of stay, device utilization and antibiotic
usage, exceptions being ASIS score, abdominal surgery and stroke (Table 1).
HH compliance during both periods was >70 %
(73.2% and 86.6% during the open and closed
periods, respectively; RR 1.18, 95 % CI 1.15–1.22).
The presence of gauze at CVC site was 98.3 % and
98.8 % during the open and closed periods, respectively (RR 1.01, 95 % CI 1.00–1.01) and the correct
condition of gauze was 95.8 % and 97.0% during the
same periods (RR 1.01, 95% CI 1.01–1.02).
For CVC-BSI, the incidence density rate and percentage of patients were each statistically significantly
lower in the closed compared to the open period
(Table 2). The distribution of microorganisms is given
in Table 3.
We examined the timing of when the first CVC-BSI
was acquired comparing the open and closed i.v. infusion containers (Fig. 2). The majority (70 %) of
patients had a CVC in place for f4 days. In the closed
period, the timing of the first CVC-BSI remained
relatively constant (0.8% at days 1–3 to 1.4 % at days
7–9), whereas during the open period it increased (2 %
at days 1–3 to 5.8% at days 7–9). Overall, the chance
of a patient acquiring a CVC-BSI was significantly
decreased by 61 % in the closed period (Cox proportional hazard ratio 0.39, P=0.0043). There was no
statistically significant difference between the two
Time to BSI in open and closed container
1045
Table 2. Incidence of CVC-associated BSI (LCBI and CSEP), CAUTI, VAP, and mortality during the
two study periods
CVC days (n)
CVC-associated BSI (n)
CVC-associated BSI/1000 CVC days
Patients with CVC-associated BSI (%)
Urinary catheter days (n)
CAUTI (n)
CAUTI/1000 catheter days
Mechanical ventilator days (n)
VAP (n)
VAP/1000 mechanical ventilator days
Deaths (n)
Patients (n)
Patients who died (%)
Open infusion
container period
(N=608)
Closed infusion
container period
(N=565)
3545
29
8.2
4.8 %
2133
7
3.3
1039
4
3.8
25
608
4.1 %
3426
12
3.5
2.1 %
2135
4
1.9
999
7
7.0
30
565
5.3 %
RR
95 % CI
P value
0.43
0.45
0.22–0.84
0.23–0.86
0.011
0.014
0.57
0.17–1.95
0.36
1.82
0.53–6.20
0.33
1.29
0.77–2.17
0.33
CVC, Central vascular catheter ; BSI, bloodstream infection ; LCBI, laboratory-confirmed bloodstream infections ; CSEP,
clinical primary nosocomial sepsis ; CAUTI, catheter-associate urinary tract infection ; VAP, ventilator-associated pneumonia ; RR, relative risk ; CI, confidence interval.
Table 3. Microbial profile of CVC-associated BSI (LCBI) during the
two study periods
Microorganism
Open infusion
container period
Closed infusion
container period
Culture-documented BSIs
10
8
Gram-positive bacteria, n (%)
Staphylococcus aureus
Coagulase-negative staphylococci
Enterococcus spp.
Corynebacterium spp.
7 (70 %)
1
5
1
0
6 (75 %)
3
1
1
1
Gram-negative bacteria
Escherichia coli
Pseudomonas spp.
2 (20 %)
1
1
0 (0 %)
0
0
Yeasts
Candida spp.
1 (10 %)
1
2 (25 %)
2
CVC, Central vascular catheter ; BSI, bloodstream infection ; LCBI, laboratoryconfirmed bloodstream infections.
periods with respect to incidence of CAUTI, VAP or
mortality (Table 2).
DISCUSSION
Central venous access for administration of large
volumes of i.v. fluid, medications, blood products, or
for haemodynamic monitoring is commonly required
for critically ill patients. Unfortunately, the use of
CVCs carries a substantial risk of BSI [8, 25–33].
When CVC-BSI occurs, studies have shown increased
length of stay, increased cost and increased attributable mortality [2, 34, 35]. In Mexico, Higuera et al.
found that CVC-BSI resulted in an extra 6 days and
cost of US$11 560 [35], while in Argentina, Rosenthal
et al. reported an extra 12 days and cost of US$4888
for CVC-BSI [2]. A recent meta-analysis of the cost
studies published in the last 5 years found that the
average cost of one BSI was US$36 441 (range
US$1822–107 156) [34]. Most importantly, CVC-BSIs
1046
F. Franzetti and others
are apparently related to increased attributable mortality as reported by Pittet and colleagues [36, 37] who
cited an attributable mortality of 25 %. Indeed, CVCBSIs are largely preventable [5, 38] and randomized
trials have documented the efficacy of simple interventions, including, but not limited to, mandating use
of maximal barrier precautions during CVC insertion
[39]. Implementation of infection control programmes
(outcome and process surveillance plus education and
performance feedback) has been shown to be effective
in reducing rates of CVC-BSI [23, 24].
Most epidemics of infusion-related BSI have been
a direct consequence of contamination of infusate
or catheter hubs [1]. Intrinsic contamination of parenteral fluids (microorganisms introduced during
manufacture) is now considered very rare in North
America [1]. Widespread use of closed infusion systems has also reduced the risk of extrinsic contamination of infusate during administration in the
hospital setting.
Many hospitals throughout the world use open infusion systems. In this study, a glass, open i.v. infusion container was associated with a high rate of
CVC-BSI, whereas switching to a fully collapsible,
closed i.v. infusion container significantly reduced the
BSI rate. To evaluate the effect of time on CVC-BSI,
the probability of developing a CVC-BSI was assessed
in 3-day intervals during each period. In the 2002
CDC guidelines [5] the recommendation was to not
routinely replace CVC at fixed intervals. The BSI rate,
here, during the closed period remained constant and
achieved levels reported in the NNIS, whereas, the
probability of a BSI during the open period significantly increased over time and was higher than those
reported in the NNIS. Thus, by using this closed system the CDC guidelines can be followed.
When comparing results of CVC-BSI between studies, it is important to display and assess the distribution of time of CVC use across patients in order to
avoid being misled by a cross-study comparison. For
example, when the hazard function is not constant, a
study with a preponderance of 2–4 CVC days per
patient compared to a study with a preponderance of
10–12 CVC days per patient would have vastly different observed CVC-BSI rates even when the total
number of CVC days in each study, the patient
population and all other characteristics of study design and conduct are identical.
While no differences were found in mortality rates
between the two periods, it should be noted that the
power to detect such differences in the study was low
due to the small study sample size (relative to a mortality endpoint), the few BSI-related deaths, and the
short length of follow-up (relative to a mortality
endpoint).
The best approach to minimize bias is a singlestage, blinded, randomized study. This type of study
mitigates the potential effect of changes over time (e.g.
reporting classifications, diagnostic techniques, seasonality, staffing, and educational programmes) as
well as baseline differences such as demographics,
disease severity. It was not practical to conduct this
type of study because the interventional products
were different structurally and the healthcare workers
would have readily discerned the difference. To minimize the effect of confounding factors, the following
controls were implemented. No new infection control
interventions, training programmes, products or technologies were introduced during the study periods
and all of the investigators, key study personnel,
classifications and diagnostics techniques remained
constant throughout the entire study. The time effect
was mitigated by equal 12-month periods covering all
seasons of the year. A lead-in period was performed
to standardize HH and CVC care compliance practice.
In addition, the following analyses show that
the confounding effects were minimal. CAUTI and
VAP were analysed to determine if there was any
change in the ICU that might impact other healthcare-associated infections. We found a significant reduction of CVC-BSI rate but no reduction in the rates
of CAUTI or VAP. Thus, the change to a closed infusion container was associated only with the reduced
CVC-BSI rate in the study. Although HH compliance
increased between the open and closed container
periods, there is no published evidence showing that
HH compliance >70% is associated with a further
reduction in CVC-BSI rate. In addition, nurse-topatient ratios and bed occupancy rates were comparable over both study periods. The baseline effect was
minimal since the two groups had similar baseline
distributions. Although not presented in the present
study, effects of baseline covariates were examined.
Exploratory analyses showed that no baseline variable(s), either individually or collectively, affected the
overall conclusion.
In a second-level general teaching hospital in
Mexico, Munoz et al. [15] cultured running i.v. infusions and found a 29.6% contamination rate during
a baseline period. However, a multi-centre crosssectional study in the same country reported a 2 %
Time to BSI in open and closed container
contamination rate and the authors highlighted lapses
in aseptic technique, and breaks in the infusion system
while injecting i.v. medications as risk factors for inuse contamination [6]. The CDC HICPAC guideline
for prevention of CVC-BSI recommends limiting
manipulations of and entry into running infusions,
and that persons handling or entering an infusion
should first wash their hands or wear clean gloves [5].
Our findings pose questions about the safety of all
open i.v. infusion containers (rigid glass, burette or
semi-rigid plastic containers). We have demonstrated
that the adoption of a closed i.v. infusion container
will prevent cases of CVC-BSI. Many hospitals
still use open rigid or semi-rigid i.v. fluid containers
which must be vented to allow ambient air entry and
fluid egress. Switching to closed, non-vented, fully
collapsible bags, could substantially reduce rates of
CVC-BSI.
ACKNOWLEDGEMENTS
Baxter S.p.A. Italy sponsored this study at Sacco
Hospital, Milan, Italy, and provided Baxter Viaflo1
products. We acknowledge the many healthcare professionals at Sacco Hospital who helped make this
study possible.
6.
7.
8.
9.
10.
11.
12.
D E C L A R A T I O N O F IN T E R E S T
13.
Baxter Healthcare provided financial support to
Dr Rosenthal to serve as the infection control coordinator for this study.
14.
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